Company info

NewLimit is a biotechnology company working to radically extend human healthspan. We’re developing medicines to treat aging and age-related diseases by reprogramming the epigenome, a new therapeutic mechanism to restore regenerative potential in aged and diseased cells. We leverage functional genomics, pooled perturbation screening, and artificial intelligence systems to unravel the biology of aging and disease using experiments of unprecedented scale.

Description

NewLimit is recruiting a Head of Manufacturing to lead drug substance and product chemistry, manufacturing, and controls (CMC). We are creating a new class of epigenetic reprogramming medicines for aging that build upon LNP and mRNA technology. Our initial assets are progressing through the complex manufacturing cascade that these modalities entail.

In this role, you will orchestrate manufacturing for some of the first reprogramming medicines to enter human trials. You will serve as the company’s resident expert in manufacturing & controls, and manage a team of talented scientists & engineers to achieve your goals.

As part of the role you will:

• Lead manufacturing campaigns for epigenetic reprogramming medicines spanning DNA, mRNA, and lipid nanoparticle manufacturing
• Own manufacturing timelines and deliverables for the world’s first reprogramming medicines
• Orchestrate contract manufacturing organizations, debug logistical issues, and keep timelines on track
• Manage and recruit talented scientists and engineers in drug substance and drug product teams
• Get in the lab and help teach, troubleshoot, and unblock projects

Requirements

• Ph.D. in a natural science or engineering discipline (biology, chemistry; chemical engineering, industrial engineering) or B.S. and equivalent industry experience
• Experience leading drug substance or drug product manufacturing for nucleic acid therapies
• Experience supporting therapies through late preclinical and early clinical development
• Deep knowledge of mRNA drug substance manufacturing

Nice to have

• Experience managing a team of scientists or engineers
• Experience running a regulatory compliant manufacturing process or facility (GLP/GMP)
• Experience leading an LNP-mRNA therapy manufacturing campaign
• History of owning the CMC section of regulatory filings

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. NewLimit offers a competitive benefits package, which includes a 401k, healthcare coverage, and 20 days of PTO. Learn more at: https://www.newlimit.com/careers   

Company info

NewLimit is a biotechnology company working to radically extend human healthspan. We’re developing medicines to treat age-related diseases by reprogramming the epigenome, a new therapeutic mechanism to restore regenerative potential in aged and diseased cells. We leverage functional genomics, pooled perturbation screening, and artificial intelligence systems to unravel the biology of aging and disease using experiments of unprecedented scale.

Description

NewLimit is recruiting a VP of Clinical Development to plan and execute our first clinical trials. Our most advanced assets restore youthful hepatic metabolism and hold the potential to benefit diverse populations with liver disease and metabolic dysfunction. Our early stage programs have similar potential for impact in renal and inflammatory disease indications.

In this role, you will design and orchestrate clinical trials for some of the world’s first reprogramming medicines. You will serve as the company’s senior clinical scientist and as a member of our executive team.

As part of your role, you will:

• Lead and orchestrate clinical development activities in collaboration with external partners.
• Create clinical trial protocols, author and own regulatory submissions, and contribute to regulatory interactions.
• Solve the inevitable logistical bottlenecks that block progress of our clinical studies.
• Serve as a member of NewLimit’s Executive Team and contribute to budgeting, goal setting, and technical review decisions.
• Build and run a clinical development team as we approach first-in-human dosing.

Requirements

• M.D. or equivalent clinical training
• Experience planning and orchestrating first-in-human trials
• Experience with both US FDA and ex-US regulatory agencies (e.g. Australian TGA)
• Deep knowledge of Good Clinical Practices (GCP)

Nice to have

• Experience in metabolic and liver disease therapeutic areas
• Experience leading a clinical development team across multiple therapeutic areas
• Experience developing products in emerging therapeutic modalities (gene therapy, nucleic acid therapies, cell therapy)
• Experience managing both early (Phase 1/2) and late-stage (Phase 3) clinical trials

Benefits

• Health, dental, and vision insurance
• 401(k) with company match
• Industry-leading paid time off (PTO) -- 20 days/year for all employees + holidays
• Paid parental leave
• Meals and snacks on-site

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Learn more at: https://www.newlimit.com/careers